Surgery system

ABSTRACT

A surgery system comprising at least one smart instrument, a computer system, and a sensor system. The sensor system is adapted to wirelessly sense the position of the at least one smart instrument and to transmit position information to the computer system.

[0001] This application claims priority from the copending provisionalapplication Ser. No. 60/178,377, filed on Jan. 27, 2000.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates generally to a surgery system. Inparticular this invention relates to a system for displaying and guidinga series of instruments to a surgical site located relative to a body ofa patient.

[0004] 2. Description of Related Art

[0005] Traditionally, an image-guided surgery system is used to displaya position of a surgical instrument in an operating zone within the bodyof a patient. A number of frame and frameless stereotactic systems havebeen developed to assist surgeons during various procedures that requirean instrument to travel to a target within a body. Typically, a surgeonanalyzes images of the body using CT scans, MRI scans, or PET scans todetermine a location of a target and to determine a desirable trajectoryalong which the instrument should travel during a surgical procedure.The image-guided surgery system includes a position measuring system formeasuring the position of the surgical instrument. A typical imageguided system usually includes a series of surgical instruments, acomputer system, a camera or other localization device, a monitor, acabinet or stand to hold the monitor and computer, and variousconnecting equipment and accessories. The computer system is used forcalculating the positions of the instruments in a correspondingpreviously captured or real time image of a surgical site. The positionof the instrument is displayed on the image of the surgical site on themonitor. The image on the monitor shows the surgeon exactly where in theoperating zone the surgical instrument is located, without the surgeonhaving a direct view of the instrument. Image guided systems improve theaccuracy and efficiency of many surgical procedures such as complex,sight impaired neurological procedures. Known frameless stereotacticsystems utilize optical, RF, magnetic, audio, or other signal systems tocommunicate between the surgical instruments and the computer system.Typically, the surgical instruments are either tethered to the computersystem or are wireless. Wireless instruments carry a system-compatibleemitter or sensor for communication through LEDs or RF systems to thecomputer system. Tethered instruments can add complexity to the systemby limiting the range of motion of the instrument and adding additionalwires and cables to route and negotiate during the surgery. Range ofmotion of the instrument is very important during the surgery itself.Limitations must be overcome by the surgeon and can lead to inaccuraciesin the surgery.

[0006] Traditional image guided systems require a lengthy set up processwhereby the user registers reference points of the pre-establishedimage, initializes and calibrates the instruments, and registers a planof trajectory for the instruments. The initialization and calibration ofthe instruments is critical to the proper operation of the system andcan involve numerous steps and manipulations by the users. Calibrationof traditional systems involve field calibration units that must bebrought to the instruments to be calibrated. Additional software is alsooften required to be installed in order to calibrate a new instrument.Re-calibrations are often required during surgery if a new instrument isnecessary or if an instrument is dropped or damaged during use. Keepingthe calibration software up to date, and all of the instruments inproper working order during the surgery is critical. Traditional systemsalso maintain one set of software code for calibrating a specific typeof instrument. However, if there is a flaw in the instrument due to amanufacturing flaw or a flaw caused during use, the software may not beable to recognize the instrument, thereby making rendering theinstrument useless.

[0007] Many traditional systems require the manual entry ofinitialization and calibration information into the computer system.This process is lengthy and if not performed properly can result ininaccuracies in the imaging system.

[0008] During surgery, many traditional image guided systems necessitatemultiple operators, one to manipulate the instruments within the sterilefield and another to make changes to the equipment and operate thecomputer system which is often outside of the sterile field or beyondreach of the surgeon operating the instruments. The use of multipleoperators may lead to inaccuracies in the system and inefficiencies inthe operation.

[0009] The sterilization of surgical equipment is an additionalrequirement that has traditionally affected the efficacy of theinstruments and other components. Known stereotactic systems typicallyutilize system-specific surgical instruments that incorporate some typeof location sensor or emitter. These surgical instruments must besterilized carefully to ensure that the sensitive detection equipment isnot damaged. Due to the high cost of such equipment, surgeons muststerilize and reuse the surgical instrument rather than dispose of thesensor or emitter components after each use. The battery life of theinstruments may also be affected by the sterilization process andlimited battery life can impact the surgery if an instrument loses powerduring use.

[0010] Thus, what is desired is an improved image guided system thatwould improve and address these concerns. An improved system wouldprovide improved control, use, life, and precision of the instrumentsand would allow for easier set up and use of the system overall. Theimproved system would enhance component compatibility andinterchangeability, and improve the economic efficiency of the imageguided surgery system.

BRIEF SUMMARY OF THE INVENTION

[0011] It is an object of the invention to provide an image-guidedsurgery system which enables easy, fast and accurate initialization,calibration, and control of a series of image guided surgeryinstruments. This object is achieved by providing wireless instrumentswith several improvements. The instruments of this invention arewireless and have a bi-directional high speed communication system thatallows communication between the instruments and a computer system inreal time. The communication system consists of a high-speed, specificfrequency or spread frequency, infrared or RF based signaling systemlocated in the instruments and a second signaling system connected tothe computer. The instruments contain non-volatile memory circuitryallowing the instruments themselves to store information about theinstrument and communicate that information back to the computer systemthrough a communication path. The instruments memory consists of anupdateable EE Ram structure that can be completely updated or changed atany time. This feature allows the instruments of the invention to beupdated with an improved software package as the system design changesover time. This improves an instrument's life and reduces a lifetimecost of the image-guided surgery system.

[0012] The image-guided system's communication path allows thedownloading of calibration data from the instruments to the computersystem and uploading of calibration information to the instruments fromthe computer system. Control data can also be downloaded to theinstrument instructing the instrument to perform a function, such asirrigation. The patient tracker of the invention includes a zerotolerance adapter interface for connection of the tracker to aninstrument adapter or reference frame. This allows for patient setup andregistration to be completed with non-sterile instruments.

[0013] The improved communication path allows the improved instrumentsto be calibrated much easier and faster than conventional instruments.By storing the calibration information in the instruments themselves theimage-guided system of the invention is capable of re-calibratingdamaged or imperfect instruments without going through a complex fieldcalibration process. The computer system of the invention will recognizean error present in the instruments and re-calibrate the instrumentbased on the data received from the field calibration tool, eliminatinga need to remove the instrument from service to perform a lengthyre-calibration procedure. The ability to store an instrumentscalibration and emitter positions within each individual instrument alsoeases a manufacturing process that traditionally required theinstruments to be manufactured to a tight tolerance.

[0014] The instruments' communication and storage capabilities alsoallow the computer system to automatically recognize the instruments asthey are placed into a field created by the localization system. Thecamera detection system consists of one or a plurality of camera sensorsplaced in a movable sensor array assembly attached to a computer system.The camera sensors contain their own calibration data allowing thecamera to be apart from the computer system. The sensor arrayestablishes a field of detection whereby the infrared signals from theinstruments are received by the sensor array. The communication path ofthe invention allows for near instantaneous perception of a newinstrument entering the field of detection. This allows the instrumentto be immediately recognized and displayed by the computer system on animage of a surgical site displayed on a monitor. This feature allows auser to immediately use a new instrument without installing any newsoftware or calibration files onto the computer system. The instrumentcommunication system also communicates an instrument status to thecomputer system displaying instrument status information such as abattery and LED status to a user.

[0015] Another object of the invention is an improved control interfacebetween the user operating the instruments and the computer system. Theinvention accomplishes this object by providing operating controlsintegrated into the instruments. Using the wireless communication systemand control buttons located on the instruments, the user can operate thecomputer system software from a surgical field without the need for anadditional assistant to operate the computer system outside the surgicalfield. The control buttons can also be used to control auxiliaryequipment connected to the system. The function of the instrumentbuttons can be specifically configured by the user to customize theinstruments for each user. The invention image-guided surgery systemalso includes a separate remote control unit that allows further controlof the computer system from within the surgical field. The remotecontrol operates using the same communication system as the instruments.

[0016] An additional object of the invention is to provide an improvedimage-guided surgery computer cart assembly for housing the computersystem, the monitor, the camera detection system, and organizing aplurality of power supply cables and a plurality of communicationcables. The computer cart of the invention includes an interface forconnecting communication cables from the monitor and the cameradetection system to the computer. In addition the cart system includesan interface for connecting peripheral equipment such as a networkconnection, a telephone line, a plurality of microscopes, and otheroperating room equipment. The cart contains a monitor interfacecombining the low voltage power supply, video, audio, and control cablesfrom the system into a single system power cable exiting from the cart.The cart also contains a plurality of storage locations for peripheralequipment.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0017]FIG. 1 is a perspective view of a surgery system according to anembodiment of the present invention;

[0018]FIG. 2 is perspective view of a universal tracker device of thepresent invention;

[0019]FIG. 3 is a perspective view of the universal tracker deviceadapted to a general instrument;

[0020]FIG. 4 is an assembly view of the universal tracker device of FIG.2;

[0021]FIG. 5 is a perspective view of the universal tracker of FIG. 2and a portion of a patient tracking system;

[0022]FIG. 6 is a perspective view of a smart instrument in the form ofa pointer device, according to an embodiment of the present invention;

[0023]FIG. 7 is a partial assembly view of the smart instrument of FIG.6;

[0024]FIG. 8 is another partial assembly view of the pointer device ofFIG. 6;

[0025]FIG. 9 is a perspective view of a computer cart assembly of thepresent invention;

[0026]FIG. 10 is a partial assembly front view of the computer cartassembly of FIG. 9;

[0027]FIG. 11 is a rear perspective view of the computer cart assemblyof FIG. 9;

[0028]FIG. 12 is an assembly view of a sensor array for use with thesurgery system of FIG. 1, according to an embodiment of the presentinvention;

[0029]FIG. 13 is assembly view of a rear panel assembly of the presentinvention;

[0030]FIG. 14 is a perspective view of a switch box assembly of thepresent invention;

[0031]FIG. 15 is a partial assembly view of the switch box assembly ofthe present invention;

[0032]FIG. 16 is a flow diagram of a smart instrument activationprocess, according to an embodiment of the present invention;

[0033]FIG. 17 is a second flow diagram of a smart instrument activationprocess, according to an embodiment of the present invention;

[0034]FIG. 18 is a flow diagram of a patient tracking system using auniversal tracker device activation process, according to an embodimentof the present invention;

[0035]FIG. 19 is a diagrammatic illustration of a display screen with aninitial banner, according to an embodiment of the present invention;

[0036]FIG. 20 is a diagrammatic illustration of the display screen ofFIG. 19 with a second banner;

[0037]FIG. 21 is a diagrammatic illustration of the display screen ofFIG. 19 with an information section having tool validation instructions;

[0038]FIG. 22 is a perspective view of a universal tracker device andanother smart instrument during a validation procedure;

[0039]FIG. 23 is a diagrammatic illustration of the display screen ofFIG. 19 during a point definition process;

[0040]FIG. 24 is a flow diagram of a process for defining markers in asurgery system, according to an embodiment of the present invention;

[0041]FIG. 25 is a diagrammatic illustration of the display screen ofFIG. 19 with point definition accuracy information,

[0042]FIG. 26 is a diagrammatic illustration of the display screen ofFIG. 19 with a main menu;

[0043]FIG. 27 is a diagrammatic illustration of the display screen ofFIG. 19 during an operation mode;

[0044]FIG. 28 is a diagrammatic illustration of the display screen ofFIG. 19 during an operation mode with a virtual tip feature;

[0045]FIG. 29 is a diagrammatic illustration of the display screen ofFIG. 19 during an guidance mode;

[0046]FIG. 30 is a second diagrammatic illustration of the displayscreen of FIG. 19 during the guidance mode;

[0047]FIG. 31 is a diagrammatic illustration of the display screen ofFIG. 19 during a select approach mode;

[0048]FIG. 32 is a second diagrammatic illustration of the displayscreen of FIG. 19 during the select approach mode;

[0049]FIG. 33 is a diagrammatic illustration of a flexible sheet or meshhaving a plurality of markers, according to an embodiment of the presentinvention;

[0050]FIG. 34A is a perspective view of a calibration and validationtool, according to an embodiment of the present invention;

[0051]FIG. 34B is a second perspective view of the calibration andvalidation tool of FIG. 34A;

[0052]FIG. 35 is a flow diagram of a calibration process for a smartinstrument using the calibration and validation tool of FIGS. 34A and34B, according to an embodiment of the present invention; and,

[0053]FIG. 36 is a perspective view of a remote control device,according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0054] With reference to drawings and in operation, the presentinvention provides a surgery system 100 having at least one smartinstrument 102. The surgery system 100 includes a sensor system 104 anda computer system 106. The computer system 106 includes a monitor 108.The computer system 106 is preferably housed in a computer cart assembly110.

[0055] The sensor system 104 is coupled to the computer system 106 andis adapted to wirelessly transmit data back and forth between the atleast one smart instrument 102 and the computer system 104 and to sensethe position of the at least one smart instrument 102 (see below).Preferably, the sensor system 104 comprises a sensor array 112.

[0056] The smart instrument 102 is operated by an operator 120 todisplay a location of the smart instrument 102 relative to a patient 122on a diagram, e.g., an image (such as an MRI or x-ray), picture,outline, line drawing, displayed on the monitor 108 during a surgicalprocedure.

[0057] With reference to FIG. 12, the sensor array 112 includes first,second, and third position sensors 1202 a, 1202 b, 12102 c for sensingthe X, Y, and Z position of a smart instrument 102. In the preferredembodiment, the first, second, and third position sensors 1202 a, 1202b, 1202 c are linear CCD cameras which are adapted to detect infrared(IR) signals generated by the smart instruments 102 (see below).

[0058] At least one infrared transceiver 1204 a, 1204 b is used tocommunicate data to and from the smart instruments 102. In the preferredembodiment, the sensor array 112 includes first and second spaced aparttransceivers 1202 a, 1202 b.

[0059] The smart instruments 102 and the transceivers 1204 a, 1204 bcommunicate via infrared signals. Preferably, the infrared signals havea baud rate at a preferred frequency of 62.5 KHz and data is transmittedusing an amplitude-shift keying (ASK) modulating method at a frequencyof 1.5 MHz. Although the present invention will now be described ascommunicating wirelessly using infrared signals, other types of wirelesstechnologies may also be used. In another embodiment, radio frequencysignals are used. In still another embodiment, communication between thesmart instruments 102 and the system 100 is accomplished using the IEEE802.11 standard, commonly referred to as “Blue Tooth”.

[0060] Returning to FIG. 1, the computer system 104 may be controlledremotely by a series of control buttons 114 located on the smartinstrument 102. The computer system 106 also contains a keyboard 116 anda mouse 118 for operating the computer system 104.

[0061] As shown, the surgery system 100 is designed to be used by anoperator 120 during a procedure on a patient 122. Preferably, thepatient 122 is located on a surgical bed or table 124.

[0062] With reference to FIGS. 2-7, in the preferred embodiment thesystem 100 includes two types of smart instruments 102, a universaltracker 200, as shown in FIGS. 2-5 and a specially adapted or specificpurpose instrument, such as a pointer instrument 500, as shown in FIGS.6-8.

[0063] With reference to FIG. 2-5, the universal tracker device 200 isshown in detail. The universal tracker device 200 may serve severalfunctions.

[0064] First, the universal tracker device 200 allows common surgicalinstruments to be used with the image guided surgery system 100.Additionally, as shown In FIG. 5, the universal tracker device 200, aspart of a patient tracking system 502 (shown in part), is used toinitialize and calibrate a dynamic reference frame centered on thepatient 122. The dynamic reference frame remains fixed relative to thepatient 122 and is adjusted relative to the operating room or computersystem 104 as the body moves or is moved relative thereto.

[0065] Additionally, the universal tracker device 200 is used tovalidate other smart instruments 102 (see below).

[0066] With specific reference to FIG. 5, the universal tracker device200 serves as part of the patient tracking system 502. The patienttracking system 502 includes the tracker device 200, an adapter 504 anda clamp device 506 for attaching the tracker device 200 to a patientreference frame 508. A preferred clamp device is known to those skilledin the art as a Mayfield clamp. The patient reference frame 508 couplesthe patient tracking system 502 to the patient 122 and is adapted tomove with the patient 122 as the patient moves or is moved. An exampleof a patient reference frame 508 is a halo.

[0067] The tracker device 200 is also used as a reference forcommunication between the surgical instruments and the computer system104. The tracker device 200 is constructed of a metal material and has ageometry designed to maximize the accuracy of the localizing system.

[0068] With specific reference to FIG. 2, the universal tracker device200 includes a plurality of infrared light emitting diodes 202, acommunication transceiver 204, and a status light 206. In the preferredembodiment, the universal tracker device 200 includes first, second,third, fourth and fifth light emitting diodes 202 a, 202 b, 202 c, 202d, 202 e.

[0069] The tracker 200 also contains a battery holder 208 for holding abattery (not shown). The battery of the tracker 200 and the other smartinstruments 102 is preferably a common lithium battery that ispre-sterilized that is to be loaded into the battery holder 208 justprior to use and is not to be re-sterilized.

[0070] The status light 206 glows in a green color for approximatelythree seconds after placement of the battery into the battery holder 208indicating that the tracker 200 is energized and has passed a series ofself diagnostic test. Once the tracker 200 is energized the tracker isattached to the clamp 258 by a zero tolerance adapter interface 210 anda release button 212. The tracker is then ready to be initialized bydepression of an activation button 214. The tracker 200 also contains avalidation point 216 for validating other smart instruments 102.

[0071] With specific reference to FIG. 3, a universal tracker device 200is shown adapted to be used with a general instrument 300, shown as apointer. Any number of common surgical instruments may be tracked withthe invention by attachment to the universal tracker device 200,including but not limited to a probe, scalpel, suction device, pin, orclamp. In order to couple the tracker device 200 to the generalinstrument 300, an adapter 302 is connected to the adapter interface 210of the universal tracker device 200 and the general instrument 300 isattached by a clamp screw 304. During use, the universal tracker servesas a communication device between the attached instrument 300 and thesensor array 104.

[0072] With reference to FIG. 4, an assembly view of a universal trackerdevice 200 is shown. The tracker 200 consists generally of a housing402, a PC board assembly 404, a cover plate 406, and a battery housing408 interconnected by a plurality of fasteners 410. The plurality ofinfrared light emitting diodes 202 are recessed into a plurality of LEDapertures 412, 412 a, 412 b, 412 c, 412 d, 412 e in the housing 402 andare held in place by a plurality of epoxy rings 414, 414 a, 414 b, 414c, 414d,414e. A plurality of electrical leads 416 connect the diodes 202to the PC board assembly 404.

[0073] The tracker 200 activation button 214 is biased in the housing402 by a compression spring 418 and contains a magnet 420.

[0074] The communication transceiver 204 includes of an IR window 422and a gasket 424. The gasket 424 serves to seal the IR window 422 wheninstalled in the housing 402.

[0075] The status light 206 is recessed through a status light aperture426 and is connected to the PC board assembly 404 by an electrical lead428. A gasket 430 forms a seal.

[0076] Attached to the PC board assembly 404 is a hall effect switch432. The battery housing 408 is attached to the cover plate 406 andcontains a positive battery contact spring 434, a negative batterycontact spring 436, and a removable cap 43 for placement of a battery(not shown) into the battery housing 408.

[0077] When the universal tracker device 200 is used as part of thepatient tracking system 502, a magnet (not shown) triggers another halleffect switch (not shown). When the universal tracker device 200 isactivated (see below), the status of the hall effect switch is sent tothe system 100. This allows the system 100 to distinguish between auniversal tracker device 200 being used as part of a patient trackersystem 502 or a universal tracker device 200 with a generic instrument300. A magnet may also be used for functional differentiation, e.g., adevice tracker is adapted to sense the present of the magnet todetermine if it is being used as part of a patient tracker system 502 ora universal tracker device 200 with a generic instrument 300.

[0078] A status of the universal tracker device battery and the diodes202 may be displayed on the monitor 108. The status feature is presentin all of the smart instruments of the present invention. The PC boardof the universal tracker 200, and all of the smart instruments 102,contain a non-volatile memory circuit (not shown) that allows theinstruments to store information about the instrument such as a uniqueID number, and calibration information in the instrument itself. Storingcalibration information in the instrument 102 allows the instrument 102to be re-calibrated in a surgical field setting. The memory circuit ofthe instruments 102 such as the tracker 200 contain updateable memory(not shown) that can be updated or changed at any time. This featureimproves the life of the smart instruments 102 such as the trackerdevice 200 by allowing the tracker device 200 to be updated with animproved software package as the image-guided system 100 changes overtime. An ability to update over time improves the life of the trackerdevice 200 and reduces a lifetime cost of the image-guided surgerysystem 100. The EE memory along with the microprocessor based circuitryof the instruments such as the tracker 200 also allows the sensor array104 and computer system 106 to immediately detect a new instrumententering the surgical field without requiring the operator 120 to load anew software program onto the computer system 106 prior to using the newinstrument 102.

[0079] The properties of the smart instruments 102, such as geometry andfunctional features, are preferably graphically displayed on thecomputer monitor 108 to enable visual display of their spatial andfunctional relationships to other smart instruments, surgical equipment,and the surgical field.

[0080] The smart instrument may also store the specific geometry of theactive part of the smart tool, i.e., the tip or the part of the toolthat is in contact with the patient or delivering some kind of energy,mechanical, electrical, sonic, electromagnetic, etc . . . , to alter thepatient's tissues. The geometry of the active part of the smartinstrument is preferably stored in memory.

[0081] With reference to FIGS. 6-8, a smart instrument 102 in the formof a specially adapted or specific purpose instrument will now bediscussed in detail. For exemplary purposes only, the smart instrument102 is shown as a pointer instrument 600.

[0082] The pointer instrument 600 has a housing 602 constructed of ametallic material and shaped in an ergonomic design to be held in theoperator's hand. The pointer instrument 600 has a plurality of infraredlight emitting diodes 604 and a communication transceiver 606 forcommunicating with the sensor system 104. The pointer instrument 600 orany smart instrument 102 may include multiple transceivers to allow theinstrument to be used in any direction. A smart instrument 102 may haveany number of light emitting diodes 604 depending upon the nature of thesmart instrument and the resolution or degree of accuracy required forits position. The pointer instrument 600 illustrated has first, second,third and fourth light emitting diodes 604 a, 604 b, 604 c, 604 d.

[0083] The control buttons 114 of the pointer instrument 600 include anup button 608, a select button 610, and the down button 612 for remotelycontrolling the computer system 104 from the smart instrument 102.

[0084] The function of the buttons 608, 610, 612 may be specificallyconfigured to suit a specific operator 120. For example, the up button608 and the down button 612 are generally configured to navigate (up anddown or left to right) through the software running on the computersystem 104, i.e., to navigate through the options available at thecurrent operation state. The select button 610 button generally is usedto actuate a current selection. However, depending on a particularoperator's preference, the buttons can be reprogrammed, e.g., tointerchange the functions of the up and down buttons 608, 612.

[0085] Controlling the computer system 104 from the instrument 102allows the operator 120 to remain in a surgical field to makeadjustments to the computer system 104 thereby improving the efficiencyof an operation.

[0086] The pointer instrument 600 also contains a work tip shown as apointer 614, a status light 616, and a battery holder 618. The statuslight 616 blinks every few seconds to indicate normal operation of theinstrument 600.

[0087] With specific reference to FIG. 7, a partial assembly view of thepointer instrument 600 is shown. The pointer instrument 600 includes thehousing 602, a battery housing 702, and a base assembly 704interconnected by a plurality of fasteners 706. The up button 608, theselect button 610, and the down button 612 are mounted in an associatedaperture 708, 710, 712 respectively, in the housing 602 by a pluralityof threaded pins 714 a, 714 b and compression springs 716 a, 716 b, 716c. Mounted under each button 608, 610, 612 is a plurality of magnetcarriers 718 a, 718 b, 718 c and magnets 720 a, 720 b, 720 c. Themagnets 720 a, 720 b, 720 c and the springs 716 a, 716 b, 716 c allowthe buttons 608, 610, 612 to toggle around the pins 714 a, 714 b.

[0088] Under the buttons 608, 610, 612 is a foam pad 722 to insureaccurate positioning of the hall sensors relative to the buttons 608,610, 612. The battery housing 702 is mounted in a channel 724 located inthe base assembly 704. The battery housing 702 contains a positive andnegative battery contact spring 726, 728 and a cap 730 for holding abattery (not shown).

[0089] With specific reference to FIG. 8, another partial assembly viewof the pointer instrument 600 is shown. The pointer instrument 600includes a cover plate 802 connected to the PC board assembly 804 byfasteners 706.

[0090] The light emitting diodes 604 a, 604 b, 604 c, 604 d are mountedinto the housing 602 with a plurality of epoxy rings 806 and areconnected to the PC board assembly 8043 by a plurality of leads 808. Thestatus light 616 is similarly mounted into the housing 602 with an epoxyring 810 and is connected to the PC board assembly 804 by lead 812. Thecommunication transceiver 606 has an IR window 814 mounted to thehousing 602 with a gasket 816 and a pair of fasteners 706 and spacers818. The PC board assembly 804 is connected to the battery (not shown)by a pair of battery leads 820.

[0091] With reference to FIG. 9, a computer cart assembly 110 of theinvention according to an embodiment of the present invention is shown.The computer cart assembly 110 consists of a cabinet 902 mounted on fourwheels 904 (only three are shown) with four corresponding wheel locks906 for activation to prevent the cart assembly 110 from movingunintentionally. Mounted to the cabinet 902 by a monitor extension post908 and a pivotable monitor extension arm 910 is the monitor 108. Themonitor 108 of the preferred invention is a flat panel high resolutionmonitor. The monitor 108 is connected to the computer system 106 by amonitor cable 912 that is routed along the monitor extension arm 910 andthrough the monitor extension post 908. Mounted on the cabinet 902 is akeyboard tray 914 and a mouse tray 916 for holding the keyboard 116 andthe mouse 118, respectively.

[0092] The sensor array 112 is mounted to the cabinet 902 by a sensorarray extension post 918, a pivotable vertical sensor array extensionarm 920, and a pivotable horizontal sensor array extension arm 922.

[0093] The cabinet 902 includes first and second front cabinet doors 924a, 924 b.

[0094] With reference to FIG. 10, the computer cart assembly 110 isshown with front cabinet doors 924 a, 924 b in an open position. Thefront cabinet doors 924 a, 924 b expose a computer workstation assembly1002, a disk bay and storage assembly 1004, and a localizer 1006. Aswitch panel assembly 1008 is also shown mounted within the keyboardtray 914.

[0095] With reference to FIG. 11 a rear view of the computer cartassembly 110 is shown. Mounted on the rear of the cart assembly 110 is arear panel assembly 1102, a cover 1104, and a switch box assembly 1106.

[0096] Returning to FIG. 12, an assembly view of the sensor array 112 isshown. The sensor array 112 is connected by a plurality of fasteners1206 to a mounting plate 1208 and a universal mount 1210. The universalmount 1210 connects the sensor array 112 to the sensor array horizontalextension arm 922.

[0097] As discussed above, the sensor array 112 includes a plurality ofposition sensors 1202 and a plurality of transceivers 1204. In thepreferred embodiment, the plurality of sensors are cameras able todetect infrared light and the transceiver 1204 communicate usinginfrared light. Alternatively, the infrared transceivers 1204 could beRF transceivers.

[0098] The position sensors 1202 contain their own calibrationinformation allowing the localizer 1006 to be placed away from thesensor array 112 in the computer cart assembly 902. The sensor array 112establishes a detection field whereby the signals from the smartinstruments 102 are received by the sensor array 112. In order tofunction properly, the smart instruments 102 must be placed within thedetection field in order for the computer system 106 to recognize theposition of the smart instruments 102.

[0099] With reference to FIG. 13 an assembly view of the rear panelassembly 1102 is shown. The panel assembly 1102 consists of a housing1302 for mounting of a monitor interface assembly 1304 and a videoamplifier 1306 and coordinating a plurality of associated cables, cords,and plugs (as described below). The panel assembly 1102 includes anexternal modem port 1308 connected to a phone cable 1310, a data port1312 connected to a patch cable 1314, and a SCSI port 1316 connected toa SCSI cable 1318. The panel assembly 1102 also contains a plurality ofcommunication cables 1320 and a video cable 1322 that are routed throughthe panel assembly 1102 and connected to the monitor interface assembly1304. The monitor interface assembly 1304 contains a monitor cable plug1324 and a sensor array plug 1326. The panel assembly 1102 also includesa power cord 1328.

[0100] With reference to FIG. 14, the switch box assembly 1106 is shown.The switch box assembly 1106 contains a top 1402 and a front panel 1404that contains a plurality of communication ports 1406, a plurality ofmedical grade outlets 1408, a fused power entry module 1410, an AC poweroutlet module 1412, and an AC power entry module 1414. The switch boxassembly 1106 and the panel assembly 1104 allow for a connection of acomputer network, a telephone line, a plurality of microscopes, and aplurality of other operating room equipment (not shown).

[0101] With reference to FIG. 15, the switch box assembly 1106 is shownwith a back and a side panel (not shown) removed. The fused power entrymodule 1410, the AC power outlet module 1412, and the AC power entrymodule 1414 are shown interconnected to each other and to the pluralityof outlets 1408 by a plurality of wires 1502. The plurality of outlets1408 are connected to a plurality of universal in-line plugs 1504 by theof wires 230. Mounted to the top 1402 is a cart power control assembly1506 that houses the universal in-line plugs 1504. Also housed on thecart power control assembly 1506 is an image guided cart UPS micro 1508and an image guided cart switch interface micro 1510. The micro internalto the switch box allow for easy power up and power down of the completesystem. A single push of the on button will turn the system on andpushing the standby button will turn the system off. During turn off,the micros synchronizes the Windows operating system shutdown and powerto eliminate system crashes.

[0102] Any number of smart instruments 102 may be active at any onetime. The surgery system 100 operates on a scanning cycle which has alength determined by the number of smart instruments 102 (includinguniversal tracker devices 200) being tracked. In the preferredembodiment, the image guided surgery system 100 only tracks the locationof the smart instrument 102 currently being used by the operator 120 andany active universal tracker device 200 (see below).

[0103] As described below, the system 100 displays a computer graphic onthe monitor 108 representing the patient 122 or a portion of thepatient's body. The graphic can be a two-dimensional, three-dimensionalor multi-planer, e.g., a picture, x-rays, an MRO image, outline, linedrawing or any other representation of the patient 122. The computersystem 106 receives information from the sensor system 104 regarding anactive smart instrument's position and matches up this position with thegraphic representing the patient 122. In one embodiment, the system 100displays a line on the monitor 108 representing the active smartinstrument 102. In another embodiment, the system 100 displays a graphicdepicting the active smart instrument 102.

[0104] With reference to FIG. 16, activation of a new smart instrument102 will now be discussed. In a first process block 1602, a new smartinstrument 102 is placed in a ready to be activated state. When a smartinstrument 102 is powered up, i.e., by insertion of the battery, it isin a ready to be activated state. In a second process block 1602, theoperator 120 actuates the activation button 214 or the select button 610so that the image guided surgery system 100 recognizes the smartinstrument 102.

[0105] Each smart instrument 102 has a unique serial number. Withreference to FIG. 17 in the preferred embodiment, the activation of anew smart instrument 102 may occur at the beginning of each scan cycle.In a third process block 1702, the surgery system 100 generates arequest for any new tool to identify itself. Preferably, the computersystem 106 (through the transceivers 1204 a, 1204 b) generates a NewTool Inquiry Package Signal. The New Tool Inquiry Package Signalincludes a serial number identification for a target tool 102 and arequest for the tool's serial number. The serial number identificationfor a target tool is set to a default value, e.g., zero (0). Only smartinstruments 102 that are in the ready to be activated state and whoseactivation button 214 is actuated respond to a request to smartinstruments having a serial number equal to the default value.

[0106] If a fourth process block 1704, if no response is received to theNew Tool Inquiry Package Signal within a predetermined time period, thenthe system 100 continues with its normal scans in the fifth processblock 1706.

[0107] In a sixth process block 1706, if a new smart instrument 102 isready to be activated, the smart instrument 102 responds to the New ToolInquiry Package Signal and the system 100 stops the scanning.

[0108] In a seventh process block 1708, the new smart instrument 102 andthe computer system 104 then communicate back and forth to relay theinformation the computer system 104 requires in order to initial the newsmart instrument 102 to add it to the scanning process. After thisprocess is done, then control proceeds to the normal scanning cycle inthe fifth process block 1706.

[0109] The above process must be completed for each smart instrument 102to be used during the procedure. Typically, each smart instrument 102 tobe used is initialized prior to the start of the procedure. However, newtools 102 may be added at any time.

[0110] The following is a list of the data that may be stored within thesmart instruments 102. Some or all of this data may be transmitted tothe computer system 106 during the initialization process (see above).

[0111] Serial Number: This is the unique electronic serial number forthe smart instrument 102 that is used to identify the smart instrument102 to the system 100.

[0112] Model Number: This is the model number of the smart instrument102. The computer system 106 may utilize this information to retrieveinformation regarding the smart instrument 102 stored on the computersystem 106 such as a graphic to be displayed on the monitor 108 whilethe smart instrument 102 is being used.

[0113] Instrument Name: This is the name of the smart instrument 102.The Instrument Name is typically displayed on the monitor 108 while thesmart instrument 102 is being used.

[0114] Generic Tool Information: This is the generic type of the smartinstrument 102. The computer system 106 utilizes this information tocreate graphics and other instrument parameters if a model number matchcan not be found.

[0115] Generic Type: This is a generic type for the smart instrument.Preferably, the Generic Type is one of the following: unknown,navigation tool, calibration tool, tracker, keypad, frame based tool,functional tool.

[0116] Tip Type: This is the type of tip on the instrument. Type of tipsinclude: cylinder, sphere, cone, truncated cone, and blade.

[0117] Minimum LEDs: This is the minimum number of LEDs that must beseen by the sensor system 104 for the smart instrument 102 to berecognized.

[0118] Dimensional Data: The Dimensional Data represents the physicalsize of the smart instrument 102 and may include a radius, a bottomradius, a bottom width, a length, a top radius, a top width, and athickness.

[0119] Number of LEDs: This is the total number of infrared lightemitting diodes on the smart instrument 102.

[0120] LED on Time: This is the amount of time that an infrared LED isactivated.

[0121] Tip Position: This is the position of the smart instrument's tipin relation to the instrument's coordinate system. Preferably, the TipPosition includes an X, Y, Z, yaw, pitch, and roll value.

[0122] Tip Correction: Tip Correction represents a correction factor forthe position of the tip as a result of manufacturing tolerances and/ortip displacement.

[0123] Button Parameters: The Button Parameters define the buttonspresent on a smart instrument 102. The Button Parameters may include thenumber of buttons, a clock delay, and a button timeout.

[0124] Number of Calibration Points: This is the number of calibrationpoints on a smart instrument 102.

[0125] EERAM Revision: This is the revision level for the informationstored on the EERAM.

[0126] RMS Match: This is the parameters used to calculate the match ofthe instrument LEDs.

[0127] LED Position: This parameter contains the position of a LED inrelation to the smart instrument's coordinate system. Typically, therewill be an LED position for each LED contained on an smart instrument102. Preferably, the LED Position includes an X, Y, Z, and a X, Y, and Zcomponent of a normal vector.

[0128] Button Function: This parameter defines the function of a buttonon the smart instrument 102.

[0129] Calibration Point: The position of the smart instrument'scalibration point in relation to the instrument's coordinate system.Preferably, the Calibration Point includes an X, Y, X and radius value.

[0130] With reference to FIG. 18, operation of the universal trackerdevice 200 as a component in the dynamic reference frame and validationof another smart instrument 102 using the universal tracker device 200will now be explained.

[0131] In an eighth process block 1802, the universal tracker device 200is coupled to the patient tracking system 502. The universal trackerdevice 200 must be positioned to ensure optimal alignment of the lightemitting diodes 202 with the sensor array 104. The universal trackerdevice 200 must also be positioned within a working volume of the system100. There should be no obstacles that interrupt the infrared beamsbetween the universal tracker 200 and the sensor array 112. Furthermore,the universal tracker 200 should be positioned to give complete accessto the surgical site.

[0132] At this point, the computer system 106 must also be initialized.With reference to FIG. 19, the computer system 106 displays a displayscreen 1900 on the monitor 108. The display screen 1900 includes abutton bar 1902, an information section 1904 and a display section 1906.In the preferred embodiment, when the computer system 106 isinitialized, a banner 1908 instructing the operator 120 to activate thetracking device 200 is displayed.

[0133] In a ninth process block 1804, once the universal tracker 200 isin position the operator 120 momentarily depresses the activation button214, as described above, to activate the universal tracker 200. Withreference to FIG. 20, once the universal tracker device 200 has beenactivated a banner 2002 is displayed indicating that no active tool isvisible to the system.

[0134] In a tenth process block 1806, a smart instrument 102 must beactivated. Returning to FIG. 20, once the smart instrument 102 has beenactivated, a graphic or pictogram 2004 of the smart instrument 102(based on the Serial number, Model Number, Generic Tool Information orGeneric Type) and the Name of the smart instrument 102 is displayed inthe information section 1904 of the display screen 1900. Once the smartinstrument 102 has been activated, the red banner 2002 will disappear.

[0135] After the smart instrument 102 has been activated, it must thenbe validated, i.e., its position relative to the patient tracker 502must be verified. With reference to FIG. 21, instructions 2102 on thevalidation procedure are displayed in the information section 1904 ofthe display screen 1900. Furthermore, a background of the graphic 2004is displayed in the color red to illustrate that the active tool 102 hasnot been validated.

[0136] With reference to FIG. 22, the smart instrument 102 is validatedby placing the tip of the smart instrument 102 at the center of thevalidation point 216 of the tracker device 202 and actuating the selectbutton 610. When the select button 610 is activated, the sensor system104 detects the firing of the diodes 604 and transmits raw positioninformation to the system computer 106.

[0137] In one embodiment, the localizer 1006 converts the raw positioninformation into the position of the individual diodes 604 and transmitsthis information to the computer system 106. The computer system 106utilizes this information to determine the position and orientation ofthe smart instrument 102. In another embodiment, the localizer 1006converts the raw position information into the position and orientationinformation of the smart instrument 102 and/or computer system 106 andtransmits this information to the computer system 106. The conversion ofthe raw position information by the localizer 1006 is well known in theart and is therefore not further discussed.

[0138] If the validation procedure is successful, the computer system106 advances to the next step. Otherwise, the validation procedure maybe redone through actuation of the select button 610 or the smartinstrument 102 can be re-calibrated (see below).

[0139] With reference to FIGS. 23 and 24, the system 102 may utilize aplurality of markers 2308 a, 2308 b, 2308 c, 2308 d located on a portionof the patient's body 122 in order to accurately register the surgicalfield relative to the graphic displayed in the display screen 1900. Inan eleventh process block 2402, the position of each marker 2308 a, 2308b, 2308 c, 2308 d is defined.

[0140] With specific reference to FIG. 23, the display section 1906 isdivided into first, second, third, and fourth sub-sections 2302 a, 2302b, 2302 c, 2302 d. The first, second and third sub-sections 2302 a, 2302b, 2302 c contain MRI images of the patient's head. The fourthsub-section 2302 d contains a computer image 2304 representing the headof the patient with the positions of the markers 2308 a, 2308 b, 2308 c,2308 d indicated.

[0141] In this example, there are three markers represented by thenumbers 1, 2, and 3 in the fourth sub-section 2302 d. The markers 2308a, 2308 b, 2308 c, 2308 d may be of several different types includingsticker or screw-in posts. A graphic 2306 showing the screw-in post typeor bone markers 2308 a, 2308 b, 2308 c is shown in the informationsection 1904. The graphic 2306 is for information purposes only and isnot an actual picture of the patient 126.

[0142] Additionally, with reference to FIG. 33, a mesh or sheet 3302made of a flexible material may be draped or placed over a portion ofthe patient 122. The mesh 3302 has a layer of light adhesive of one sideand a plurality of markers 3304 on the other side. Preferably, themarkers 3304 are spaced apart at known intervals. The mesh 3302 is stuckonto the patient 122 using the adhesive. The markers 3304 are thusvisible by the localizer 1006 and can be used by the system 100 forsurface matching as well as patient tracking.

[0143] In one embodiment, the markers 3304 are stickers which are usedwith a smart instrument 102 to register the positions of the markers3304 within the system 102.

[0144] In another embodiment, the sheet 3302 is a smart instrument andthe markers 3304 are light emitting diodes. Preferably, the position ofthe diodes is determined on the field. The diodes are connected to abreakout box and can be positioned using different means of attachmentto any tissue of the patient, e.g., bone or skin. The geometry of thesheet 3302 can then be initialized to two modes: tracking of rigidtissues after determining the spatial relationships of the diodes withthe sensor array. The second mode is to track soft tissue displacementor deformations over time. Using the first mode (tracking), thepositional information of the sheet's diodes can be used to register thetracked feature of the patient to an image data set, e.g., a CT scan,using, for example, surface matching techniques.

[0145] Returning to FIG. 23, the images contained in the sub-sections2302 a, 2302 b, 2302 c, 232 d are used to define the reference pointsrepresented by the markers 2308 a, 2308 b, 2308 c in the system 100. Aset of instructions 2310 are displayed in the information section 1904.

[0146] Additionally, light emitting diodes (not shown) may be fixedlyattached to the markers 2308 a, 2308 b, 2308 c for automaticregistration of the marker positions in the system 100.

[0147] As shown by the graphic 2004, the active smart instrument 102 isa pointer. In order to define the position of the markers 2308 a, 2308b, 230 c within the system, the operator 120 places the tip of thepointer 102 on the marker and actuates the select button 610. Themarkers 2308 a, 2308 b, 2308 c must be defined in the order instructed,i.e., 1, 2, 3. However, a marker 2308 a, 2308 b, 2308 c may be skippedaltogether by scrolling through them using the control buttons 114.

[0148] The system 100 preferably allows the operator 120 to zoom androtate the images in the display section 1906 to facilitate thisprocess.

[0149] Returning to FIG. 24 in a twelfth process block 2404, after eachmarker 2308 a, 2308 b, 2308 c has been defined in the system 100 theaccuracy of the defined positions is checked. In the preferredembodiment, this is accomplished by calculating the relative agreementbetween the defined positions and known positions. If any of the definedpositions differ from the expected position by over a predeterminedthreshold, then the marker position must be re-defined. In the preferredembodiment, the predetermined threshold is one (1) millimeter (mm) forskin markers and two and ½ (2.5) millimeters for the bone markers.However, these values may be adjusted.

[0150] With reference to FIG. 25, the display screen 1900 showing thecalculated accuracy is shown. The points represented by the markers 2308a, 2308 b, 230 c and their deviation are listed in the informationsection 1904. Even if a defined point is within the predetermineddeviation, the system 100 allows the operator 120 to re-define the pointto optimize the accuracy of the system 100.

[0151] With reference to FIG. 26, during operation the informationsection 1904 includes a main menu 2602. The main menu 2602 includes anoperation button 2604, a guidance mode button 2606, an approaches button2608, a registration button 2610, and a view selection button 2612.

[0152] With reference to FIG. 27, upon actuation of the operation button2604 the information section 1904 includes an operation panel 2702. Theoperation panel 2702 includes a trajectory section 2704, a virtual tipsection 2706, an image freeze toggle button 2708, a take snapshot button2710, a zoom in button 2712, and zoom out button 2714, and a main menubutton 2716.

[0153] The trajectory section 2704 includes information on the distancebetween the actual position of a smart instruments 102 and the desiredoperating point. For example, the Trajectory Section 2704 describes thetype of trajectory 2720 required to reach the operating point, i.e.,“Straight”. A colored dot 2718 denotes the color of an image on thescreen 2724 representing the trajectory. A text box 2722 contains thedistance from the actual position of the smart instrument 102 and thedesired operating point.

[0154] The virtual tip feature allows the operator 120 to virtuallyextend the tip of the smart instrument 102 on the monitor 108. This isusual for visualizing an extended instrument during operation. Thevirtual tip section 2706 includes a distance text box 2726, adecrementing button 2728, an incrementing button 2730 and a reset button2732. The distance text box 2726 contains the virtual extended distanceof the smart instrument 102. The decrementing button 2728, incrementingbutton 2730 and reset button 2732 are used to decrease, increase, andset to zero the virtual extended distance of the smart instrument andmay be operated via the mouse 116 or control buttons 114.

[0155] The virtual tip feature is useful for aligning a navigatedinstrument along a planned trajectory. The virtual tip feature is alsouseful to determine the depth of a biopsy. With the tip of the smartinstrument 102 placed at the entry point the distance to target is shownin the text box 2722. The virtual tip can then be extended this amount(to the target) and the alignment of the instrument along the plannedtrajectory is easily done.

[0156] With reference to FIG. 28, a virtual tip extension of 50 mm isshown. When the tip is extended a warning signal 2802 is displayed toremind the operator 120 that a virtual probe is being displayed.

[0157] The required trajectory from the actual point of the smartinstrument 102 to the desired operating point is represented by thedashed line 2804. The actual tip of the smart instrument 102 isrepresented by the first perpendicular line segment 2806. The secondperpendicular line segment 2808 represents the virtual tip.

[0158] The freeze image toggle button 2708 is used to toggle betweenfrozen or static onscreen images and real-time images. Real-time imagesare displayed during normal operation.

[0159] The take snapshot button 2710 captures the images displayed inthe display section 1906 in a graphic file, preferably in a the TIFFfile format, and stores the image into a patient archive.

[0160] The zoom in and zoom out buttons 2712, 2714 are used to zoom inand zoom out on the images displayed in the display section 1906.

[0161] The main menu button 2716 returns the system 100 to the main menu2602.

[0162] With reference to FIGS. 29 and 30, operation of the system 100 inthe guidance mode will now be explained. The guidance mode is used toguide the insertion of a smart instrument 102 into a pre-defined entry.An pre-defined entry point 2902 is displayed in the display section1906. Preferably, the entry point 2902 remains centered in the displaysection 1906. A first target 2904 represents the tip of the active smartinstrument 102. A second target 2906 represents the end of the smartinstrument 102. The goal is to line up the first and second targets2904, 2906 indicated that the current smart instrument 102 is at theproper orientation. The guidance mode can only be selected if there isat least one approach trajectory 2908.

[0163] With reference to FIGS. 31 and 32, actuation of the approachesbutton 2608 allows the operator 120 to view defined trajectories. Withspecific reference to FIG. 31, after the approaches button 2608 has beenactuated, the information section 1904 includes a list 3102 of allpre-defined approaches. In this example, only one approach (“Straight1”) 3104 has been defined. One or more of the sub-sections 2302 a, 2302b, 2302 c, 2302 d includes an image or representation of the patient 122illustrating the defined entry point 3106 and trajectory 3108. A modifyentry point button allows the operator 120 to modify the defined entrypoint.

[0164] With specific reference to FIG. 32, after the modify entry pointbutton has been actuated, the information section 1904 includesinstructions 3202 on how to modify the entry point. Generally, theoperator 120 places the tip of the active smart instrument 102 at adesired point and actuates the select or apply button 610 on the smartinstrument 102 thereby redefining the entry point 3106. The operator 120can then actuate either the up (forward) button 608 or the down (back)button 612 to accept or cancel the change.

[0165] With reference to FIGS. 34A and 34B, a calibration and validationtool 3400 is shown. The tool 3400 is a smart instrument having fourinfrared LEDs 3402 a, 3402 b, 3402 c, 3402 d, a battery holder 3402 fora battery (not shown), a status light 3406, an infrared transceiver3408, and a activation button 3410. When the universal tracker ismounted to a non-guided tool the calibration tool can be used calibratethe combined instruments tip position into the tracker. The calibrationtool 3400 can also be used to re-calibrate another smart instrument 102if the smart instrument 102 could not be validated (see above) or if itis suspected that the smart took 102 has been compromised. Additionally,the calibration tool 3400 can be used to validate another smartinstrument 102 if, for example, a patient tracker system 502 with auniversal tracker device 200 is not being used.

[0166] Like all smart instruments 102, the calibration tool 3400 must beinitialized. The calibration tool 3400 must be placed on a solid surfacewithin the working volume of the system 100 with the LEDs 3402 a, 3402b, 3402 c, 3402 d in view of the sensor system 104. Then it isinitialized through actuation of the activation button 3410 (see above).

[0167] The calibration tool 3400 includes at least one validation point3412. In the preferred embodiment, the tool 3400 includes fourvalidation points 3412 a, 3412 b, 3412 c, 3412 d adapted to varioustypes of tool tips. The four validation points 3412 a, 3412 b, 3412 c,3412 d are mounted at the top of four columns 3414 a, 3414 b, 3414 c,3414 d. The four columns 3414 a, 3414 b, 3414 c, 3414 d are coupled to abase 3416. An upper and lower plate 3418, 3420 are slidably coupled tothe four columns 3414 a, 3414 b, 3414 c, 3414 d. First and second upperplatform screws 3418 a, 3418 b and first and second lower platformscrews 3420 a, 3420 b lock the upper and lower plates 3418, 3420 to thefour columns 3414 a, 3414 b, 3414 c, 3414 d, respectively.

[0168] The upper plate 3418 includes a first aperture 3422. A firstlever 3424 is coupled to a first plurality of flanges 3426. The firstlever 3424 operates the first plurality of flanges to variably closeand/or change the size of the first aperture 3422.

[0169] The lower plate 3420 includes a second aperture 3428. A secondlever 3430 is coupled to a second plurality of flanges 3432. The secondlever 3430 operates the second plurality of flanges 3432 to variablyclose and/or change the size of the second aperture 3428.

[0170] With reference to FIG. 35, the process to calibrate a smartinstrument 102 will now be explained. In a thirteenth process block3502, the station 3400 is initialized (see above). In a fourteenthprocess block 3504, the first and second apertures 3422, 3428 are fullyopened via the first and second levers 3424, 3430, respectively.

[0171] In a fifteenth process block 3506, the smart instrument 102 to becalibrated is then inserted through the first and second apertures 3422,3428 until the tip of the smart instrument 102 is against the base 3416.

[0172] In a sixteenth process block 3508, the platform screws 3418 a,3418 b, 3418 c, 3418 d are loosened and the upper and lower plates 3418,3420 are slid apart as far as the shape of the smart instrument 102allows.

[0173] In a seventeenth process block 3410, the platform screws 3418 a,3418 b, 3420 a, 3420 b are then tightened.

[0174] In an eighteenth process block 3412, the first and second levers3424, 3430 are used to close the first and second apertures 3422, 3428around the smart instrument 102.

[0175] In a nineteenth process block 3414, the operator 120 then pressesthe activation button 214 or select button 610 on the smart instrument102. The LEDs 202, 604 on the smart instrument 102 are then read by thelocalizer system. Position information is relayed to the computer system106 which calculates new calibration information for the smartinstrument 102. In the preferred embodiment, the new calibrationinformation is then sent back to the smart instrument 102 and storedthereon. Whenever this smart instrument is thereafter activated, the newcalibration is then sent to the computer system 106 for use.

[0176] It is recommended that after a smart instrument has beencalibrated, that it be validated. The calibration and validation tool3400 can also be used to perform the validation. The operation of thecalibration and validation tool 3400 to validate a smart instrument 102is similar to the use of the universal tracker device 200.

[0177] With reference to FIG. 36, the system 100 includes a remotecontrol device 3600 which allows the operator 120 to move through andmake selections from the display screen 1900 on the monitor 108.Preferably, the remote control device 3600 can be sterilized and placedwith the work volume of the system.

[0178] The remote control device 3600 includes a housing 3602 with abattery holder 3604. A plurality of control buttons 3606 allow theoperator 120 to control the system 100, an infrared transceiver 3608 anda status light 3610. In the preferred embodiment, the remote controldevice 3600 includes an upward button 3606 a, a downward button 3606 b,a next button 3606 c, a back button 3606D, and a select or apply button3606E.

[0179] As discussed above, the system 100 operates on a scanning cyclewhich has a length based on the number of smart instruments 102 active.At the beginning of each cycle, the system 100 sends out a new toolinquiry package system which requests that any new smart instruments 102identify themselves (see above). If there are no new tools, then thesystem 100 cycles through the active smart instruments 102 to determinetheir position.

[0180] In order to determine a smart instrument's 102 position, thesystem 100 has stored the number of LEDs in each smart instrument 102that has been activated. Only one LED 202, 604 can be read at a time.

[0181] In the preferred embodiment, the system 100 first sends out ainitial signal identifying a smart instrument 102 by serial number thatit should prepare for firing its LEDs 202, 604. The initial signal alsorequest status information from the targeted smart instrument 102. Thisstatus information may include battery life, any faults, activatedcontrol buttons, etc, . . . . The target smart instrument 102 deliversthe requested status information to the system 100.

[0182] The initial signal may also include commands for the smartinstrument 102. For example, for a smart instrument 102 adapted as anirrigator may respond to on and off commands.

[0183] The system 100 then requests that the smart instrument 102 firesoff each LED one at a time in order to be recognized by the system 100.

[0184] In one embodiment, the system 100 cycles through all active smartinstruments and attempts to determine their position.

[0185] In another embodiment, the system 100 only determines theposition of any universal tracker device 200 coupled to a patienttracked system 502 and a smart tool 102 currently being used by theoperator 120. In this embodiment, when the operator 120 picks up (analready activated) smart instrument 102, the operator 120 must actuatethe activation button 214 or the select button 610. This signals to thesystem 100 that the smart instrument 102 is currently being used. In thepreferred embodiment, the system 100 cycles through all activeinstruments 102 but temporarily sets the number of LEDs on theinstruments 102 not being used to zero (0).

[0186] As discussed above, the control buttons 114 are programmable andare adapted to operate, i.e., navigate through, the software running onthe computer system 106. The control buttons 114 are also used in thevalidation and calibration operations, as discussed above. For example,on the smart instrument 600 shown in FIG. 6, the select button 610 isused to validate the smart instrument 600, calibrate the instrument 600and activate the instrument 600. The system 600, based on the positionof the smart instrument 600 performs the correct operation. For example,if the smart instrument 600 position indicates that the pointer 614 islocated at the validation point 216 of the universal tracker device 200(or the validation tool 3400), then the system 100 performs a validationoperation upon activation of the select button 610. If the smartinstrument 600 is in the calibration tool 3400, then a calibrationoperation is performed when the select button 610 is activated. Thisfeature can also be used with other input devices to the system 100. Forexample, if the operator 120 needs to push a button on the keyboard 116,the operator 120 can simply point at the desired key and activate theselect button 610.

[0187] Other aspects, objects, and features of the present invention canbe obtained from a study of the drawings, the disclosure, and theappended claims.

1. A smart instrument for use in a surgery system, comprising: a housing; a plurality of light emitting diodes coupled to the housing and being adapted to fire independently; and, a transceiver adapted to communicate with the surgery system.
 2. A smart instrument, as set forth in claim 1 , wherein the smart instrument includes a memory circuit for storing information related to the smart instrument.
 3. A smart instrument, as set forth in claim 2 , wherein the smart instrument is adapted to transmit via the transceiver the information stored on the memory circuit in response to a received signal.
 4. A smart instrument, as set forth in claim 1 , wherein the smart instrument includes a status light.
 5. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be for a specific purpose.
 6. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a pointer.
 7. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a scalpel.
 8. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a probe.
 9. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a validation tool for other smart instruments.
 10. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a suction device.
 11. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a pin.
 12. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be used as a clamp.
 13. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be interchangeably coupled with a plurality of generic instruments.
 14. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be interchangeably coupled with a patient tracking system.
 15. A smart instrument, as set forth in claim 1 , wherein the smart instrument is adapted to be interchangeably coupled with a patient tracking system and at least one generic instrument.
 16. A smart instrument, as set forth in claim 1 , wherein the smart instrument includes an activation button.
 17. A smart instrument, as set forth in claim 16 , wherein the smart instrument is adapted to transmit via the transceiver information stored on a memory circuit in response to a received signal.
 18. A smart instrument, as set forth in claim 17 , wherein the information includes a status of the activation button.
 19. A smart instrument, as set forth in claim 1 , wherein the smart instrument includes a plurality of control buttons for remotely controlling the surgery system.
 20. A smart instrument, as set forth in claim 19 , wherein the smart instrument is adapted to transmit via the transceiver information stored on a memory circuit in response to a received signal.
 21. A smart instrument, as set forth in claim 20 , wherein the information includes a status of control buttons.
 22. A smart instrument, as set forth in claim 1 , wherein the smart instrument includes an up button, a select button, and a down button.
 23. A smart instrument for use in a surgery system, comprising: a housing; a plurality of light emitting diodes coupled to the housing and being adapted to fire independently; a transceiver adapted to communicate with the surgery system; an activation button; an adapter interface coupled to the housing; and, a release button operatively couple to the adapter interface, where the smart instrument is adapted to be interchangeably coupled with a patient tracking system and at least one generic instrument.
 24. A smart instrument, as set forth in claim 23 , including a memory circuit for storing information related to the smart instrument.
 25. A smart instrument, as set forth in claim 24 , wherein the information stored on the memory circuit is updated by the surgery system.
 26. A smart instrument, as set forth in claim 24 , wherein the information stored on the memory circuit includes calibration information.
 27. A smart instrument, as set forth in claim 26 , wherein the calibration information is updateable using a calibration station.
 28. A smart instrument, as set forth in claim 24 , wherein the smart instrument further includes a validation point for validating other smart instruments.
 29. A smart instrument for use in a surgery system, comprising a housing; a plurality of light emitting diodes coupled to the housing and being adapted to fire independently; a transceiver adapted to communication with the surgery system; a plurality of control button for remotely controlling the surgery system; and, a work tip coupled to the housing.
 30. A smart instrument, as set forth in claim 29 , including a memory circuit for storing information related to the smart instrument.
 31. A smart instrument, as set forth in claim 30 , wherein the information stored on the memory circuit is updated by the surgery system.
 32. A smart instrument, as set forth in claim 30 , wherein the information stored on the memory circuit includes calibration information.
 33. A smart instrument, as set forth in claim 32 , wherein the calibration information is updateable using a calibration tool.
 34. A smart instrument, as set forth in claim 29 , wherein the smart instrument further includes a validation point for validating other smart instruments.
 35. A surgery system, comprising: at least one smart instrument; a computer system; a sensor system adapted to wirelessly sense the position of the at least one smart instrument and to transmit position information to the computer system.
 36. A surgery system, as set forth in claim 35 , wherein the at least one smart instrument includes a memory circuit for storing information related to the smart instrument, and wherein the at least one smart instrument is adapted to wirelessly transmit the information to the computer system.
 37. A surgery system, as set forth in claim 36 , wherein the information includes calibration information.
 38. A surgery system, as set forth in claim 35 , wherein the sensor system uses infrared signals.
 39. A surgery system, as set forth in claim 35 , wherein the sensor system uses radio frequency signals.
 40. A surgery system, as set forth in claim 35 , wherein the sensor system uses the IEEE 802.11 communication standard.
 41. A surgery system, as set forth in claim 35 , wherein the sensor system includes a sensor array.
 42. A surgery system, as set forth in claim 35 , wherein the sensor array includes at least one linear CCD camera and an infrared transceiver.
 43. A surgery system, as set forth in claim 35 , wherein the sensor array includes three linear CCD cameras and at least one infrared transceiver.
 44. A surgery system, as set forth in claim 35 , wherein the computer system includes a monitor.
 45. A surgery system, as set forth in claim 44 , wherein the computer system is adapted to display a diagram of a patient on the monitor.
 46. A surgery system, as set forth in claim 45 , wherein the diagram is of one of an image, picture, outline and line drawing of at least a portion of the patient.
 47. A surgery system, as set forth in claim 45 , wherein the computer system is adapted to display a representation of the at least one smart instrument on the diagram.
 48. A surgery system, as set forth in claim 47 , wherein the representation of the at least one smart instrument is a line.
 49. A surgery system, as set forth in claim 47 , is a graphic.
 50. A surgery system, as set forth in claim 35 , wherein the computer assembly includes: a localizer coupled to the sensor system; a computer workstation coupled to the localizer; and a monitor coupled to the computer workstation.
 51. A surgery system, as set forth in claim 50 , wherein the at least one smart instrument includes a plurality of infrared light emitting diodes.
 52. A surgery system, as set forth in claim 51 , wherein the localizer is adapted to receive the position information from the sensor system, determine a relative position of each of the plurality of infrared light emitting diodes.
 53. A surgery system, as set forth in claim 52 , wherein the localizer is adapted to transmit the relation positions of the plurality of infrared light emitting diodes to the computer workstation.
 54. A surgery system, as set forth in claim 52 , wherein the localizer is adapted to determine a relative position and orientation of the at least one smart instrument as a function of the relative positions of the plurality of infrared light emitting diodes and transmit the relative position and orientation to the computer workstation.
 55. A surgery system, as set forth in claim 35 , including: a patient tracking system; a universal tracker device coupled to the patient tracking system; wherein the sensor system is adapted to wirelessly sense the position of the universal tracker device and to transmit position information to the computer system.
 56. A surgery system, as set forth in claim 55 , wherein the universal tracker device includes a validation point.
 57. A surgery system, as set forth in claim 56 , wherein the validation point is used to validate the at least one smart instrument.
 58. A surgery system, comprising: at least one smart instrument; a patient tracking system; a universal tracker device coupled to the patient tracking system; a localizer; a computer workstation coupled to the localizer; a monitor coupled to the computer workstation; a sensor system coupled to the localizer and being adapted to wirelessly sense the position of the at least one smart instrument and the universal tracker device and to transmit position information to the localizer.
 59. A surgery system, as set forth in claim 58 , wherein the at least one smart instrument includes first plurality of infrared light emitting diodes and the universal tracker device includes a second plurality of light emitting diodes, wherein the localizer is adapted to receive the position information from the sensor system and to determine a relative position of each of the first and second plurality of infrared light emitting diodes.
 60. A surgery system, as set forth in claim 59 , wherein the localizer is adapted to transmit the relation positions of the first and second plurality of infrared light emitting diodes to the computer workstation.
 61. A surgery system, as set forth in claim 59 , wherein the localizer is adapted to determine a relative position and orientation of the at least one smart instrument and the universal tracker device as a function of the relative positions of the first and second plurality of infrared light emitting diodes and transmit the relative position and orientation of the at least one smart instrument and the universal tracker device to the computer workstation.
 62. A surgery system, comprising: at least one smart instrument; a patient tracking system; a universal tracking system having a validation point and being coupled to the patient tracking system; a localizer; a computer workstation coupled to the localizer; a monitor coupled to the computer workstation; and, a sensor system adapted to wirelessly sense the position of the at least one smart instrument and to transmit position information to the localizer, wherein the validation point is used to validate the at least one smart instrument.
 63. A surgery system, comprising: at least two smart instruments; a computer system; a sensor system adapted to wirelessly sense the position of the at least two smart instruments and to transmit position information to the computer system.
 64. A surgery system, as set forth in claim 63 , wherein the computer system includes a monitor and wherein the computer system is adapted to display a diagram of a patient on the monitor.
 65. A surgery system, as set forth in claim 64 , wherein the computer system is adapted to display a representation of one of the at least two smart instruments on the diagram.
 66. A surgery system, as set forth in claim 65 , wherein the one of the at least two smart instruments is in use.
 67. A surgery system, as set forth in claim 66 , wherein the computer system is adapted to alternatively determine the position of the at least two smart instruments.
 68. A surgery system, as set forth in claim 66 , wherein the computer system is adapted to only determine the position of the one of the at least two smart instruments.
 69. A surgery system, comprising: a sheet of flexible material having a plurality of markers on a first side; a smart instrument adapted to be placed in contact with the plurality of markers; a computer system; a sensor system adapted to wirelessly sense the position of the at least one smart instrument and to transmit position information to the computer system.
 70. A surgery system, as set forth in claim 69 , wherein the flexible material is a mesh.
 71. A surgery system, as set forth in claim 69 , wherein the sheet of flexible material includes a layer of adhesive on another side.
 72. A validation tool for validating a smart instrument in a surgery system, comprising: a base; four columns coupled to the base; at least one validation point coupled to one of the four columns; and, a plurality of infrared light emitting diodes coupled to the base.
 73. A calibration tool for calibrating a smart tool in a surgery system, comprising: a base; four columns coupled to the base; a plurality of infrared light emitting diodes coupled to the base; and, an upper plate and a lower plate slidably coupled to the four columns, the upper and lower plates each including an aperture for receiving the smart tool during a calibration process.
 74. A surgery system, comprising: at least one smart instrument; a validation tool, the validation tool including: a base; four columns coupled to the base; at least one validation point; and, a plurality of infrared light emitting diodes coupled to the base; and, a computer system; a sensor system adapted to wirelessly sense the position of the at least one smart instrument and the calibration tool and to transmit position information to the computer system, wherein the validation tool is adapted to validate the at least one smart instrument.
 75. A surgery system, comprising: at least one smart instrument; a calibration tool, the validation tool including: a base; four columns coupled to the base; a plurality of infrared light emitting diodes coupled to the base; an upper plate and a lower plate slidably coupled to the four columns, the upper and lower plates each including an aperture for receiving the smart tool during a calibration process; and a computer system; a sensor system adapted to wirelessly sense the position of the at least one smart instrument and the calibration station and to transmit position information to the computer system, wherein the calibration station is adapted to calibrate the at least one smart instrument.
 76. A surgery system, comprising: a smart instrument being composed of a flexible material; and having a plurality of light emitting diodes on a first side; a computer system; and, a sensor system adapted to wirelessly sense the position of the plurality of light emitting diodes and to transmit position information to the computer system.
 77. A surgery system, as set forth in claim 76 , wherein the computer system is adapted to determine the contour of the smart instrument and perform a surface matching operation with a known contour.
 78. A surgery system, as set forth in claim 76 , wherein the smart instrument is part of a dynamic reference frame.
 79. A surgery system, comprising: at least one smart instrument, having at least one control button a computer system; and, a sensor system adapted to wirelessly sense the position of the at least one smart instrument and to transmit position information to the computer system and to transmit status information of the at least one control button, wherein the computer system is adapted to perform an operation based on the activation of the control button and the position of the at least one smart instrument. 